Kornimate/medical-research-clean huggingface dataset:
gadget-pd genetic and digital diagnosis of essential tremor and parkinson's disease trial

Conditions: Parkinson Disease; Essential Tremor

Summary: the proposed study will capitalize on the early predictive information stored in an individual's genetic risk for parkinson disease (pd) in combination with the subtle features of tremors that can be extracted from movement data gathered by modern compact accelerometers in order to determine if accurate discrimination of essential tremor (et) from pd can be achieved. both of these technologies have a proven but somewhat limited ability to inform diagnosis of pd or differentiation of pd from et - especially at early stages of the disease. the investigators hypothesize that a combination of prior genetic risk and current disease symptomology can synergize for accurate and early discrimination of pd from et and ultimately inform a cost effective approach to movement disorder diagnosis. in this study, the investigators will collect blood from individuals with confirmed late-onset diagnosis of pd and et. gold standard diagnosis status will be determined via the unified parkinson's disease rating scale (updrs) - the accepted clinical gold standard for parkinson's disease diagnosis. dna will be extracted from blood samples to characterize the genetic risk of individuals for pd via proven genetic risk models. in addition, participants will wear a wristwatch-like accelerometer device that will track their movements (tremors) at high temporal resolution and transmit movement data via a smartphone. cognitive distraction tasks will be administered via mobile phones while simultaneously collecting movement data. predictive tremor features will be extracted from movement data via signal processing approaches - e.g. discrete wavelet transformation. a final predictive model combining movement tracking information and genetic information will be designed in attempt to distinguish pd from et individuals.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease as defined by the uk brain bank criteria and history of resting tremor, or: * essential tremor with history of resting tremor. diagnosis made by a movement disorder specialist. * midstage in disease process for parkinson's disease with history of resting tremor exclusion criteria: * dementia as defined by a mini-mental state examination cutoff score of 27 * atypical parkinsonism * akinesia/ rigidity parkinson's disease * movement disorders - stiff-person syndrome, choreatic disease, dystonia, progressive supranuclear palsy * motor neuron disease - multiple sclerosis, amyotrophic lateral sclerosis, motor neuritis, progressive bulbar palsy, progressive muscular atrophy, spinal muscular atrophy * significant neurological comorbidities: * stroke * brain cancer or brain metastases * history of bone marrow transplant * cerebral palsy and spastic paraplegia
a phase 1 study evaluating safety and tolerability of rct2100 in healthy participants and in participants with cf

Conditions: Cystic Fibrosis

Summary: this is the first-in-human study with rct2100 and is designed to provide safety and tolerability data for future clinical studies.

this is a multi-part study to assess the safety, tolerability, and biodistribution of a single ascending dose of inhaled rct2100 administered via nebulizer to healthy participants (part 1) and multiple-ascending doses of inhaled rct2100 administered to participants with cf (part 2).

Eligibility criteria:
part 1 major inclusion criteria: * healthy, adult, male or female, 18-55 years of age, inclusive, at screening. * body weight greater than or equal to 50 kg and body mass index (bmi) between 16-32 kg/m2, inclusive * the participant has a forced expiratory volume in one second (fev1) of at least 80% predicted * the participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ecg results, and physical examination findings at screening. * understands the study procedures in the informed consent form (icf), and is willing and able to comply with the protocol. part 1 major exclusion criteria: * history or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease. * the participant has supine blood pressure (bp) \>150 mm hg (systolic) or \>90 mm hg (diastolic), following at least 5 minutes of supine rest. * the participant has abnormal clinical laboratory tests at screening, as assessed by the study-specific laboratory. * the participant is a smoker or has used nicotine or nicotine-containing products 6 weeks before the first dose of study drug. former smokers with greater than 10 pack years of smoking history are excluded. part 2 major inclusion criteria: * confirmed diagnosis of cf * forced expiratory volume in 1 second ≥40% and ≤100% of predicted mean value for age, sex, and height * a) not eligible for cftr modulators based on having mutations of cftr gene on both alleles that are not responsive to cftr modulator therapy or * b) eligible for cftr modulators (based on local prescribing information) but not using cftr modulators due to intolerance or contraindications part 2 major exclusion criteria: * hepatic cirrhosis with portal hypertension, moderate hepatic impairment (child pugh score 7 to 9), or severe hepatic impairment (child pugh score 10 to 15) * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for sinopulmonary disease within 4 weeks before the first dose of study drug * lung infection with organisms associated with a more rapid decline in pulmonary status * arterial oxygen saturation on room air less than 94% at screening * values of ast, alt, alkaline phosphatase, or gamma-glutamyl transferase (ggt) ≥3×uln * treatment with a cftr modulator (kalydeco, trikafta, symdeko, or orkambi) within 12 weeks of screening other protocol defined inclusion/exclusion criteria may apply.

Keywords: cystic fibrosis cf
effectiveness and satisfaction with brief synchronous tele-psychiatry consult

Conditions: Depression

Summary: will tele-psychiatry be effective and acceptable to patients.

this pilot aims to provide tele-psychiatry consults to patients at regional mayo clinic florida primary care sites. the primary aim of this study is to assess the impact of brief tele-psychiatry consults on depression and anxiety outcomes for patients enrolled in complex care management; the secondary aim is to assess patient satisfaction with brief tele-psychiatry consults.

Eligibility criteria:
inclusion criteria 1. enrolled in complex care management 2. phq9 above 10 or gad7 above 10. exclusion criteria 1. not able to provide informed consent 2. severe cognitive impairments or sensory deficits 3. not able to understand and speak english
pulse pressure variation based intraoperative fluid management versus traditional fluid management for colonic cancer patients undergoing mass resection and anastomosis

Conditions: Intraoperative Fluid Volume; Hemodynamics; Serum Lactate; Intestinal Edema; Length of the Hospital Stay; First Time to Gastrointestinal Motion; Postoperative Complications

Summary: pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.

all patients will be assigned randomly by using computerized program to one of the two equal groups. patients will be (forty five patients per group): group a ;( control group) forty five patients will do elective open colonic mass resection and anastomosis. infusion of 6 ml/kg/hr. ringer's solution. group b; forty five patients will do elective open colonic mass resection and anastomosis. infusion of 2 ml/kg/hr. ringer's solution guided by pulse pressure variation. intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status (asa-ps) i and ii patients. * patients scheduled for elective open colonic mass resection and anastomosis. exclusion criteria: * serious cardiac arrhythmia. * peripheral artery disease. * an ejection fraction below 30%. * a pulmonary pathology.
in utero smoking and premature cellular senescence

Conditions: Chronic Obstructive Pulmonary Disease

Summary: actually, there is an increasing number of arguments for a premature origin of chronic adult's diseases, as the chronic obstructive pulmonary disease (copd). several factors interacting with the foetal or postnatal lung growth are associated with early and long-lasting respiratory functional changes susceptible to contribute very significantly to the arisen of a copd in the adulthood. it is possible that these situations reflect phenomena of premature cellular senescence, recently involved in the physiopathology of the copd. an in utero exposition to cigarette smoking is one of these situations, because it is known to induce, not only functional respiratory changes, but also multiple diseases in the child which could testify of cellular ageing phenomena. our project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children the study will be driven in human newborn child's, with comparison of the length of the telomeres in circulating lymphocytes (umbilical blood is collected), according to the exposure in in utero smoking and also according to the degree of hypotrophy. this study will be a pilot study completed by an animal experimental study.


Eligibility criteria:
inclusion criteria: * born weight upper or equal to the 10th percentile and absence of smoking declared by the mother * born weight lower than the 10th percentile and absence of smoking declared by the mother * born weight upper or equal to the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day * born weight lower than the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day exclusion criteria: * gestationnel age 37 limited companies * low(weak) declaratory(declarative) maternal smoking (1 in 4 cigarettes a day) * pathologies associated by the newborn child (deformations, foetal suffering, infection maternofœtale, respiratory distress syndrome)
integrating support persons into recovery

Conditions: Opioid Addiction

Summary: integrated support persons into recovery (inspire) is a 4-year research project that tests whether integrating a patient's support person into a patient's treatment with buprenorphine/naloxone can improve outcomes. the study will examine whether a counseling program called craft for a support person, such as a family member, spouse or friend, can improve patient outcomes.

opioid use disorders (ouds) have reached an all-time high and have devastating effects on the individual, family, and community. while medication treatment for oud saves lives, rates of treatment drop out are very high. in addition, existing oud treatments neglect the impact of untreated oud on the family, and ignore the potential role family members and support persons (sps) could have on encouraging long-term recovery. incorporating the patient's support system may be an important way to improve treatment retention. the proposed study evaluates a counseling program for concerned family members, spouses, and friends called community reinforcement and family training (craft), which is successful at engaging and retaining patients in substance use treatment. while promising, no studies have evaluated whether craft can help patients remain on medication treatment for oud, provided by community health clinics. if effective, this could save lives and help both patient and family member health outcomes. patient and sp pairs will be recruited from community health clinics throughout northern and southern california. patients taking oud medication treatment will be recruited and randomly assign half of the sps to receive craft; the other half would receive treatment-as-usual. patients and sps will be interviewed three and twelve months later to evaluate whether patients with craft sps stay in oud treatment longer, and whether patient and sp health outcomes improve.

Eligibility criteria:
patient inclusion criteria: * 18 and older * on buprenorphine treatment for oud * has an eligible support person that participates support person inclusion criteria: * 18 and older * frequent contact with the patient * willing and available to try craft patient exclusion criteria: * \< 18 years and older * not currently receiving buprenorphine * not able to provide consent support person exclusion criteria: * \< 18 years and older * currently has a problem with heroin or opioid pills * not able to provide consent * actively using other substances such that their presence in group would be contraindicated

Keywords: opioid medication assisted treatment community reinforcement approach and family training
the relationship between autobiographical memory and motivation

Conditions: Psychosis

Summary: people with a diagnosis of psychosis often experience low motivation and pleasure when thinking about doing future activities. this leads, quite understandably, to doing fewer activities they used to enjoy and not taking up opportunities to do new activities. one model suggests that this may be partly due to difficulties using memories of previous events to help boost motivation and anticipation before a future activity. research shows that people with psychosis may recall previous events in less detail. these memories therefore may not be as helpful as they could be for motivation. this study will investigate this by asking people with experience of psychosis and low motivation who are seen by a care team in south london and maudsley nhs trust to attend two research sessions. in the first session they will be asked to recall memories of events from their lives and the researcher will assess how detailed they are and how much they refer to the past and future. alongside this task people will also be asked to complete measures of symptoms such as low pleasure and motivation as well as a measure of depression. these will be used to find out if the detail and specificity of the memories are related to these symptoms in people with psychosis. the second half of the study will then investigate whether additional prompts to support positive memory retrieval can increase the specificity of this and subsequently improve mood, motivation and self-belief. participants will be randomised to one of two groups. the clinical group will be guided through their memory recall using prompts and a control group will be asked to recall positive memories without prompts. if we show that supporting memory recall is beneficial then memories for past events may be an important target for future therapies.


Eligibility criteria:
inclusion criteria: * a diagnosis of non-affective psychosis (as determined by medical records). * above 18yrs old. * a score of at least 18 on the clinical assessment interview for negative symptoms. * a sufficient command of the english language to engage with the research materials exclusion criteria: * lack of capacity to provide informed consent. * primary diagnosis of intellectual disability, head injury, substance misuse or known organic cause of psychosis

Keywords: negative symptoms autobiographical memory
a phase i/ii trial to evaluate oral hp568 tablets in patients with er+/her2 advanced breast cancer

Conditions: Breast Cancer

Summary: this is a phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of hp568 alone and in combination with palbociclib in patients with er+/her2- locally advanced or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. women aged 18-75 years old (inclusive of both ends) at the time of signing the informed consent form. 2. patients with locally advanced inoperable or recurrent or metastatic breast cancer er+/her2- advanced breast cancer is confirmed by histopathology have confirmed that the primary and/or metastatic lesion. 3. previously received at least 1-line endocrine therapy (endocrine therapy duration ≥ 6 months) and ≤ 2-line chemotherapy (≤ 2-line chemotherapy limited to dose escalation stage) for the recurrence or metastasis stage of the disease. the third stage : inclusion of patients who have not received prior treatment but are suitable for cdk4/6i therapy. 4. disease progression confirmed by imaging occurs during or after the last systemic anti-tumor treatment before the first medication. exclusion criteria: 1. known or suspected allergy to any ingredient of hp568 formulation, and allergy to any ingredient of palbociclib (only applicable to stage iii). 2. within 42 days prior to the first administration, fluvistran was used; other endocrine therapies such as tamoxifen, toremifene, letrozole, anastrozole, and exemestane were used within 14 days prior to the first administration. 3. previously received other er-rotac drugs such as arv-471. 4. within 6 weeks before the first administration of hp568 in this study, nitrosoureas or mitomycin were used; received any anti-tumor treatment, including immunotherapy, chemotherapy, radiotherapy, or targeted therapy, within 28 days prior to the first administration (or of the drug's 5 half lives,take the shorter one).
hydromorphone for perioperative analgesia in lung tumor ablation parallel controlled

Conditions: Pulmonary Nodule; Ablation

Summary: this randomized, parallel controlled, single blind trial is designed to evaluate the efficacy and safety of hydromorphone versus morphine for perioperative analgesia in lung tumor ablation.

although the consensus of relevant guidelines and clinical studies recommend the use of opioids for perioperative analgesia in pulmonary tumor ablation surgery, there is a lack of specific analgesic programs for clinical reference. in view of the advantages of clinical application of hydromorphone and the lack of evidence for its application in perioperative analgesia of pulmonary tumor ablation, this study aims to explore the efficacy and safety of hydromorphone in perioperative analgesia of pulmonary tumor ablation, and provide some reference and suggestions for perioperative analgesia of pulmonary tumor ablation.

Eligibility criteria:
inclusion criteria: * voluntarily attend and sign the informed consent form in person; * patients undergoing selective pulmonary tumor ablation; * the eastern collaborative oncology group (ecog) defines an activity status score of 2 or less; * the estimated survival time is more than 3 months; * age 18-80, both sexes. exclusion criteria: * severe coagulation dysfunction that cannot be corrected; * history of severe cardio-cerebrovascular and respiratory diseases; * patients allergic to test drugs or contrast media; * patients with opioid addiction; * patients with cognitive dysfunction; * participated in other clinical investigators within three months; * investigators or their family members directly involved in the trial; * those who are deemed unfit to participate in the study by the investigator.
study of efficacy and safety inc280 in patients with advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: this study is establish whether inc280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-met pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib. patients will be randomized in a 2:1 ratio to receive inc280 at 600mg bid plus best supportive care (bsc) or placebo plus bsc, until disease progression or intolerable to study treatment. patients treated with placebo plus bsc will have the opportunity to receive inc280 treatment upon documented further disease progression (recist 1.1) per investigator's discretion after unblinding. patient will be stratified to geographical region (asia vs rest of world ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).

study was cancelled by sponsor prior to enrollment of patients.

Eligibility criteria:
inclusion criteria: * confirmed c-met pathway dysregulation.- hepatocellular carcinoma stage b or c according to the barcelona clinic liver cancer staging classification. - current cirrhotic status of child-pugh class a with no encephalopathy. - documented disease progression during or after discontinuation of sorafenib treatment or intolerance to sorafenib treatment. - measurable disease as determined by recist v1.1. - ecog performance status ≤ 1 exclusion criteria: * previous local antineoplastic therapy or investigational drug completed less than 5 half-lives of the agent prior to randomization and have not recovered from clinically significant toxicity from such treatment to grade ≤1 by the nci-ctcae. - received any targeted therapy other than sorafenib. * active bleeding within 28 days prior to screening visit including variceal bleeding (esophageal varices should be treated according to standard practice and procedure completed 28 days prior to screening visit). - clinically significant venous or arterial thrombotic disease within past 6 months.

Keywords: inc280, advanced hepatocellular carcinoma, c-met pathway dysregulation.
the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

Conditions: Infertility; Female Infertility; Frozen-thawed Embryo Transfer

Summary: the purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

for a pregnancy to occur, the embryo must implant in a receptive endometrium during the window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day cycle. early studies have suggested that assessing endometrial thickness with the use of ultrasound may be an alternative to invasive techniques such as endometrial biopsy for attempting to determine a receptive endometrium for frozen-thawed embryo transfer (fet). a preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for endometrial receptivity, below which many physicians would cancel an embryo transfer. however, in most studies in the literature, endometrial thickness was measured either on the day of hcg in fresh embryo transfer cases or on the last day of estrogen treatment in thawed embryo transfers. there are a limited number of studies evaluating the luteal period, embryo transfer day and endometrial thickness. accordingly, in this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

Eligibility criteria:
inclusion criteria: 1. woman aged 18-40 years 2. presence of high quality (\>2bb) blastocyst 3. hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles 4. presence of high quality blastocyst cryopreserved by vitrification method. 5. a single embryo transfer exclusion criteria: 1. presence of uterine pathology 2. participants whose optimal endometrial image cannot be obtained due to uterine position 3. participants whose treatments were canceled for any reason before embryo transfer 4. participants which had embryo transfer on the day 2 or 3 (at the cleavage stage) 5. participants who had 2 embryo transfer 6. presence of low quality (\<2bb) blastocyst 7. \> 15% loss of viability in the embryo during embryo thawing

Keywords: infertility female infertility frozen- thawed embryo transfer female